Finding the Common Road to Quality for Single-Use Materials

– GMP requirements touch every single use assembly used in clinical studies to commercial manufacturing.  The drug product produced in clinical studies are given to patients.
– GMP practices followed in producing the single use assemblies will ensure that there is no risk to patients in clinical trials and future commercial products.
IF WE CAN”T PROVE GMP WHAT HAPPENS?
-Single use assemblies will not be accepted by regulatory agencies and internal quality departments as an alternative to stainless steel tanks.
-The perception will continue that there is inadequate quality controls on single use assemblies as GMP practices are not adequately followed.
– Implementation of single will be inhibited
Presented by Dr Trishna Ray-Chaudhuri, Senior QC Scientist in Direct Materials in Global Analytical Sciences & Technology / Global QC, Genentech
Trishna Ray-Chaudhuri is a Senior QC Scientist in Direct Materials in Global Analytical Sciences and Technology / Global QC at Genentech wholly own subsidiary of Roche in South San Francisco, CA.   Since 2011, she has been responsible for supporting the implementation of single use systems in terms of system performance and reliability through specification development.  Before joining Roche, she was an independent consultant providing support in the development of single use systems.  Prior to this, she was Senior Process Engineer at Sartorius-Stedim working in the development and implementation of single use systems.  Trishna started her career in Monsanto Plastics prior to its acquisition by Bayer.
Trishna has a PhD. and MS in Polymer Engineering from the University of Tennessee and a BS in Chemical Engineering from Rutgers College of Engineering.
 
Sponsored by Pall Biotech

 
Presented by Dr Hélène Pora, Vice President Technical Communication & Regulatory Strategy , Pall Biotech
Dr Hélène Pora is Vice President Single Use Technology within Pall Life Sciences, where she has the global responsibility for the marketing and development of Pall single use technologies. Hélène has been instrumental in the development of Pall single use technologies for the last 20 years. She is as well heavily involved in quality and regulatory aspects of single use technology. Hélène has over 30 years of experience working for the biopharmaceutical industry, the last 26 years within Pall Corporation.
She speaks regularly at conferences about single use technology with a strong focus on validation and over all process integration aspects, she is as well involved in different working groups in the industry involved in standards development and is on the board of BPSA and SUTAP.
 
Driving Quality and Responsiveness in Single- Use Technologies
Single-use technologies require a shift of responsibility from biomanufacturers to suppliers to enable production of safe and reliable drugs. One of the pre-requisites for efficient supply is to have standardized processes to design and manufacture single-use systems.
Pall has developed a unique design, quality and business tool to drive quality and responsiveness, and to support standardization of single-use technologies. We will take you through the functionalities of this system and demonstrate what benefits it brings to end users when implementing single-use technologies in a regulated environment.
 
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